Esophageal Cancer Clinical Trial
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
Full Description
OBJECTIVES:
Primary
Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.
Secondary
Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus
Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
Stage I-III disease
No known distant metastases
No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
No supraclavicular metastases
PATIENT CHARACTERISTICS:
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Adequate bone marrow function
Hepatic
Adequate hepatic function
No unstable or uncompensated hepatic disease
Renal
Creatinine ≤ grade 2 by Common Toxicity Criteria
Adequate renal function
No unstable or uncompensated renal disease
Cardiovascular
No unstable or uncompensated cardiac disease
Pulmonary
No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
No unstable or uncompensated respiratory disease
Other
Not pregnant or nursing
Fertile patients must use effective contraception
No known hypersensitivity to gefitinib or any of the excipients
No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
No evidence of severe or uncontrolled systemic disease
No other significant clinical disorder or laboratory finding that would preclude study participation
PRIOR CONCURRENT THERAPY:
Endocrine therapy
Concurrent stable-dose steroids allowed
Surgery
Recovered from any prior oncologic or other major surgery
Other
More than 30 days since prior nonapproved or investigational drug
No prior therapy for this or any other malignancy
No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)
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There is 1 Location for this study
Rochester New York, 14642, United States
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